Kornimate/medical-research-clean huggingface dataset:
the medacta international gmk sphere post-marketing surveillance study

Conditions: Arthritis; Traumatic Arthritis; Rheumatoid Arthritis; Poly-arthritis; Avascular Necrosis

Summary: this is a post-marketing surveillance of gmk sphere knee prosthesis.

the clinical performance of the gmk® sphere, manufactured by medacta international, will be evaluated by a multicentre, prospective clinical surveillance study. the elective orthopaedic centre (eoc), in epsom, surrey, will be the study coordinating centre. four further centres will participate in the clinical study, for five total centres. each participating centre will recruit approximately 100 patients. patient recruitment will cease when a cohort of 500 gmk® sphere knee replacements have been implanted.

Eligibility criteria:
inclusion criteria: * a disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis * patients must be between the age of 18 and 80 at the time of consent * listed for total knee replacement surgery. * patients who are willing to give informed written consent exclusion criteria: * progressive local or systemic infection * muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable * severe instability secondary to advance destruction of condylar structures or loss of integrity of the medial or lateral ligament * any patient who cannot or will not provide informed consent for participation in the study * those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems * patient whose bmi exceeds 40 * any case not described in the inclusion criteria
coaching for caregivers of children with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this pilot study has two aims. the first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.

this study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. a one-group pre-post treatment design will be used. consented caregivers will receive coaching via face-to-face or via the phone. each caregiver will participate in up to 10 coaching sessions. each coaching session will last up to 90 minutes. coaching sessions will be audiorecorded and transcribed verbatim. outcomes of coaching on caregivers' self-identified goals will be assessed using the canadian occupational performance measure.

Eligibility criteria:
inclusion criteria: * female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury * female primary caregivers have legal guardianship of their child with spinal cord injury * speak, read and comprehend english * be available for face-to-face coaching * have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection * able to verbalize changes in their own participation or their child's participation during initial screen * written consent exclusion criteria: * severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating md or medical team member * abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating md or medical team member
prediction of cognitive properties of memantine for neurodegenerative diseases

Conditions: Alzheimer Disease; Battery

Summary: the early assessment of new drugs for alzheimer's disease remains difficult because of the lack of predictive end-point. the use of a battery including different parameters could improve this early development of new drugs. nevertheless, the interest of such a battery should previously be validated with the yet marketed ad drugs.

the aim of the present study is to test the effect of a 15-day treatment with memantine on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers. this multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in france (lille, marseille and toulouse). 18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with memantine, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. the primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters

Eligibility criteria:
inclusion criteria: * 18-30 year old male non-smoker subjects * subject without cognitive impairment or cognitive complaint (moca\>26, mac nair scale\<15) * subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,...) * subject without major medical or surgical history * subject without current chronic disease * subject without current cerebral disease * subject without vascular or metabolic risk factor * subject without history or current mental disease or addiction (mini) * subject without lesion on mri * subject without abnormal electrical activities on eeg * subject without use of chronic treatment or psychotropic drugs or substances * french speaker subject and able to understand the test instructions exclusion criteria: * subject with dementia or cognitive decline identified by moca \< 26 * subject with vascular or metabolic risk factor * subject with history or current mental disease or addiction * subject with family history of young-onset dementia * subject with family history of chronic or severe neurological or mental disease (first degree relatives) * subject receiving a chronic treatment * subject with claustrophobia or contra-indication to mri * subject unable to understand the test instructions

Keywords: alzheimer memantine biomarkers battery cognition imaging neuropsychology
coenzyme q10 in relation of the lipid peroxidation, antioxidant enzyme activities in coronary artery disease patients

Conditions: Coronary Artery Disease

Summary: coenzyme q10 (ubiquinone) is recognized as an endogenous fat-soluble antioxidant in the mitochondrial membrane and considered as a preventive factor for coronary artery disease (cad). however, the relationships between coenzyme q10 and the prevention of the risk of cad are still inconsistent. the purposes of this study are to investigate the relation of coenzyme q10 concentration with the blood lipid levels, plasma homocysteine, the markers of lipid peroxidation (tbars, ox-ldl),antioxidant enzymes activities (catalase, glutathione peroxidase, superoxide dismutase)and to examine the association with the risk of cad.the cad patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery (n = 100). the second year is a double-blind, placebo-controlled intervention study. cad subjects (n = 60) are randomly assign to one of the three groups (coenzyme q10 supplements 60 mg/d, 150 mg/d, and placebo groups, n = 20/group). intervention is going to administration for three months. the third year is a case-control study. the control group （n = 100） is comprised of healthy individuals with normal blood biochemical values, and match by age and gender with the first year cad subjects (case group). fasting blood samples will be obtain to determine the concentration of coenzyme q10, homocysteine, the markers of lipid peroxidation,antioxidant enzymes activities. the differences between case and control groups will be compared by using student's t-test. conditional logistical regression model will be performed to calculate the odds ratio for cad based on coenzyme q10 level. hopefully, the results of this study could provide the information to what has been know in cad subjects. we expect coenzyme q10 could be a preventive supplement to reduce the risk of cad.


Eligibility criteria:
inclusion criteria: * cad patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery exclusion criteria: * age \< 18 years old * pregnancy women * taking lowering lipid drug (statin)
the effect of central sensitization on treatment response in patients with fibromyalgia

Conditions: Central Sensitisation; Fibromyalgia

Summary: central sensitization (cs) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with fibromyalgia has been demonstrated in several studies. however, the effect of initial cs severity on treatment response in these patients is not fully known. in this study, it was aimed to investigate the severity of cs and its effect on treatment response in patients with fibromyalgia.

fibromyalgia is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown.it is considered to be the main member of the central sensitization-related disease group known as central sensitivity syndromes with impaired pain regulation.in various studies, hyperalgesia and allodynia, which are accepted as objective findings of central sensitization in patients with fibromyalgia, strengthen the relationship between fibromyalgia and central sensitization. the central sensitization inventory (csi) was developed in 2012 to be used in the recognition of central sensitivity syndromes in patients with fibromyalgia. a score of 40 and above is accepted in favor of central sensitization in the scale, which consists of two parts, in which central sensitization-related symptoms and diagnoses are questioned; scores of 30-39 are classified as mild, 40-49 moderate, 50-59 severe, and 60-100 very severe. parallel to the increase in the csi score, an increase is observed in patients' pain severity, disability, depressive symptoms and sleep disorders.in addition, it has been reported in the literature that factors such as pre-treatment pain severity and depression affect the treatment response.considering all these factors, it is possible that there is a relationship between the severity of central sensitization and treatment response in patients with fibromyalgia.based on this, in this study, it was aimed to investigate the effect of central sensitization severity, which was evaluated with csi before treatment, on the treatment process.

Eligibility criteria:
inclusion criteria: * diagnosing fibromyalgia according to acr 2016 criteria * between the ages of 18-65 * agree to participate in the study exclusion criteria: * history of concomitant systemic inflammatory disease, active infection and malignancy * refusing to participate in the study
mesenchymal stem cells in multiple sclerosis (mscims)

Conditions: Multiple Sclerosis

Summary: hypothesis: intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells is a safe novel therapeutic approach for patients with multiple sclerosis. mesenchymal stem cells in multiple sclerosis (mscims) is a phase i/iia trial designed to establish the safety of intravenous administration of bone marrow-derived autologous adult human mesenchymal stem cells to patients with multiple sclerosis.

disease under investigation: multiple sclerosis phase: i/iia number of patients: 10 design: 18 month cross over, single treatment at 6 months intervention: administration of bone marrow-derived autologous mesenchymal stem cells route of administration: intravenous dose: up to 2,000,000 mesenchymal stem cells per kilogram source of patients: referrals accepted from neurologists in east anglia and north london, uk referral criteria: (all 3 required) 1. clinically definite multiple sclerosis 2. expanded kurtzke disability status score 2.0 - 6.5 (inclusive) 3. evidence of optic nerve damage by * history of optic neuritis, or * relative afferent pupillary defect, or * optic atrophy on fundoscopy, or * abnormal visual evoked potential from either or both eyes suggestive of demyelination primary objective: establish the safety of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months by monitoring adverse reactions. secondary objectives: explore the efficacy of intravenously administered bone marrow-derived autologous mesenchymal stem cells at a dose of up to 2,000,000 cells/kg over 12 months on visual function by clinical, neurophysiological, and imaging assessments. outcome measures: 1. primary * adverse events 2. secondary * visual function (acuity and colour) * visual evoked potential latency * optic nerve magnetisation transfer ratio * retinal nerve fibre layer thickness (by optical coherence tomography) * brain lesion magnetisation transfer ratio * mri brain t1 hypointensity load * t cell response suppression 3. tertiary * multiple sclerosis functional composite score * expanded kurtzke disability status score

Eligibility criteria:
inclusion criteria: * clinically definite multiple sclerosis * expanded kurtzke disability status score 2.0 - 6.5 (inclusive) * evidence of optic nerve damage by: * history of optic neuritis, or * relative afferent pupillary defect, or * optic atrophy on fundoscopy, or * abnormal visual evoked potential from either or both eyes suggestive of demyelination * prolonged visual evoked potential p100 latency with preserved waveform * t2 lesion on mri optic nerve * retinal nerve fibre layer thickness on optical coherence tomography \> 40 microns exclusion criteria: * age \< 18 years * age \> 65 years * patient lacks capacity to give informed consent * presence of a severe bleeding disorder * planning a pregnancy during the trial period * current ms disease modifying therapy

Keywords: multiple sclerosis safety therapeutics mesenchymal stem cells multipotent mesenchymal stromal cells optic neuritis
thalidomide in treating patients with extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: thalidomide may stop the growth of cancer by stopping blood flow to the tumor. purpose: phase ii trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.

objectives: * determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy. * determine the toxicity of this drug in these patients. outline: this is an open-label study. patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. treatment continues for 1 year in the absence of disease progression or unacceptable toxicity patients are followed every 3 months. projected accrual: a total of 30 patients will be accrued for this study within approximately 18 months.

Eligibility criteria:
disease characteristics: * diagnosis of extensive-stage small cell lung cancer * complete or partial response after 4-6 courses of induction chemotherapy patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * at least 2 months hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study * no greater than grade 1 peripheral neuropathy prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: extensive stage small cell lung cancer
a study of amg 114 administered by subcutaneous injection for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy

Conditions: Anemia; Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of amg 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.


Eligibility criteria:
inclusion criteria: part a: - non-myeloid malignancy receiving multicycle chemotherapy - receiving non-platinum containing chemotherapy - at least 6 additional weeks of cyclic cytotoxic chemotherapy planned part b and part c: - non-myeloid malignancy receiving multicycle chemotherapy - at least 12 additional weeks of cyclic cytotoxic chemotherapy planned all parts: - chemotherapy induced anemia - greater than 6 month life expectancy - ecog 0-2 - adequate renal and liver function exclusion criteria: - chronic myeloid leukemia, aml, all, burkitt's lymphoma or lymphoblastic lymphoma - history of seizure disorder - primary hematologic disorder which could cause anemia, other than a non-myeloid malignancy - unstable angina, congestive heart failure or uncontrolled cardiac arrhythmia - uncontrolled hypertension - history of pure red cell aplasia - clinically significant inflammatory disease or active infection - iron deficiency - anc less than 0.8 x 10\^9 cells/l

Keywords: non-myeloid malignancy clinical trial
buccal evaluation of mobile beach workers

Conditions: Buccal Cavity Cancer; Labial Lipoma

Summary: tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. the prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. the objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature.

tumors in the oral region occur more frequently in men over 40, but can affect people of both sexes and all ages, even children. the prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. the objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature. firstly, information about the care, symptoms and forms of prevention will be explained for each worker approached, if the individual agrees to an oral examination, it can be performed by evaluating lips and peri-oral mucosa and within the needs of oral treatment, it can be referred for treatment at the clinic of the dentistry especialist center of santos/sp the street vendors who underwent the first assessment will be visited 2 more times according to the schedule, after the carnival of 2020 being the last assessment and thus being able to have data on the effectiveness of the information and past care during the visits made. as expected results, a greater awareness of the dangers of sun exposure, greater protection care and the ability to carry out self-examination at home being an information disseminator.

Eligibility criteria:
inclusion criteria: * be walking beach worker exclusion criteria: * not wanting to participate in the evaluation

Keywords: buccal cancer
neoadjuvant nab-paclitaxel in triple-negative or her2-positive breast cancer

Conditions: Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer

Summary: to evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for chinese patients with triple-negative and her2-positive breast cancer in the neoadjuvant setting.


Eligibility criteria:
inclusion criteria: 1. written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures. 2. age at diagnosis ≥ 18 years, female. 3. histologically confirmed diagnosis of her2-opsitive or triple-negative breast cancer. er/pr-negativity is defined as ≤1% stained cells； her2-positivity is defined as ihc 3+ or in-situ hybridisation (ish) ratio \>2.0. 4. ct2-4nanym0 or ctanyn1-3m0 5. ecog ≤ 1, lvef ≥ 55%. 6. laboratory requirements: for hematology, absolute neutrophil count (anc) ≥ 1.5 × 109 / l and platelets ≥ 100 × 109 / l and hemoglobin ≥ 90 g/l; for hepatic function, total bilirubin ≤ 1.5 × unl, ast and alt ≤ 2.5 × unl; for renal function, scr ≤ 1.5 × unl 7. patients must be available and compliant for treatment and follow-up. exclusion criteria: 1. prior chemotherapy, endocrine therapy or radiation therapy for any malignancy. 2. known or suspected congestive heart failure (\> nyha i) 3. currently active infection or severe symptomatic visceral disease. 4. definite contraindications for the use of corticosteroids or known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol 5. rior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, ptis of the cervix uteri. 6. participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry. 7. pregnant or lactating patients. patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.